Cap for Medical Injector

ABSTRACT

A medical injector including a cap remover or second cap is disclosed. The medical injector includes an injector housing defining a reservoir, a plunger rod, and a stopper engaged with a portion of the plunger rod and slidably disposed within the reservoir. The stopper being sized relative to an interior of the injector housing to provide sealing engagement with a sidewall of the injector housing. The medical injector further includes a needle having a sharpened first end and a second end in communication with the reservoir, a first cap covering the sharpened first end of the needle, and a second cap covering at least a part of the first cap. The second cap is engaged with the first cap such that removal of the second cap simultaneously removes the first cap from the first end of the needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/391,625, filed Aug. 2, 2021, which is a continuation of U.S. patentapplication Ser. No. 16/255,873, filed Jan. 24, 2019 (now U.S. Pat. No.11,110,229), which is a continuation of U.S. patent application Ser. No.15/372,650, filed Dec. 8, 2016 (now U.S. Pat. No. 10,220,157), whichclaims the benefit of U.S. Provisional Application No. 62/264,529, filedDec. 8, 2015, the disclosures of each of which are incorporated hereinby reference in their entirety.

BACKGROUND OF THE INVENTION Field of the Disclosure

The present disclosure relates generally to medical injector devices fordelivery of a fluid or liquid medicament. More particularly, the presentdisclosure relates to a safety cap and/or a cap remover for a medicalinjector device or a syringe.

Description of the Related Art

Medical injectors and syringes are well known in the prior art. Medicalinjectors may include auto-injectors and pen injectors which are capableof delivering selected doses of fluids including liquid medicaments orvaccinations to a patient. Medical injectors typically are configured toreceive a standard pre-filled glass or plastic syringe tipped with aninjection needle. These devices may include a drive member for advancinga plunger into a syringe barrel to expel a liquid medicament out throughthe needle. The required manipulation of a standard prior art hypodermicsyringe can be inconvenient, particularly where the injection isself-administered in a public environment, and many medication deliverypens, pen injectors, or other self-injectors have been developed tofacilitate self-administration of injections.

In order to maintain sterility prior to use and to reduce the risk ofincurring an accidental needle-stick, protection of the needle tip isimportant. Medical injectors are typically supplied with a rubber orplastic cap which guards the needle prior to use. Immediately prior touse, the user must remove the protective cap from the injector, such asby using the cap protector of the present invention.

SUMMARY OF THE INVENTION

In accordance with an embodiment of the present invention, a medicalinjector includes an injector housing defining a reservoir, a plungerrod, and a stopper engaged with a portion of the plunger rod andslidably disposed within the reservoir, the stopper being sized relativeto an interior of the injector housing to provide sealing engagementwith a sidewall of the injector housing. The medical injector furtherincludes a needle having a sharpened first end and a second end incommunication with the reservoir, a first cap covering the sharpenedfirst end of the needle, and a second cap covering at least a part ofthe first cap. The second cap is engaged with the first cap such thatremoval of the second cap simultaneously removes the first cap from thefirst end of the needle. The second cap may engage the first cap via afriction fit.

The medical injector further includes an interior wall defining a cavityin a proximal end of the second cap, the cavity being sized and shapedto receive at least a portion of the first cap. A plurality ofprotrusions extend inwardly from the interior wall of the second cap andmay be adapted to frictionally engage the first cap. At least one of theplurality of protrusions may include a tapered surface for aiding thesecond cap in receiving the first cap.

The first cap is formed from a first material and the second cap isformed from a second material. The first material is different from thesecond material. In one embodiment the first cap is formed from anelastomeric sleeve disposed over at least the sharpened first end of theneedle. The second material may be harder than the first material.

In one embodiment, a window may be defined through a sidewall of thesecond cap for visually viewing engagement of the second cap with thefirst cap. The medical injector may further include a liquid medicamentdisposed within the reservoir.

The second cap includes a body having a proximal end and a distal end, afirst wing flange extending from a portion of the cap body in a firstdirection, a second wing flange extending from a portion of the cap bodyin a second direction, wherein the first direction is different from thesecond direction. The first and second wing flanges may extend fromopposing sides of the cap body. The first and second wing flanges mayeach have a curved proximally directed surface and a substantially flatdistally directed surface.

Also provided herein is a cap remover including a cap body having aproximal end and a distal end, and an interior wall defining a cavitywithin the proximal end of the cap body. A protrusion extends inwardlyfrom the interior wall of the cap body. A first wing flange extends froma portion of the cap body in a first direction and a second wing flangeextends from a portion of the cap body in a second direction. The firstdirection may be different than the second direction. The first wingflange and the second wing flange include a curved proximally directedsurface and a flat distally directed surface.

In one embodiment, the protrusion includes a plurality of protrusionsextending inwardly from the interior wall of the cap body. At least oneof the plurality of protrusions may include a tapered proximal surface.

The cavity is sized and shaped to receive a needle cap covering a needletherein and the plurality of protrusions are adapted to frictionallyengage the needle cap. With the plurality of protrusions of the cap bodyengaged with the needle cap, the cap remover may disengage the needlecap from the needle upon application of a distally directed force to thecap remover. A viewing window may be defined through a portion of thecap body.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a cap remover in accordance with anembodiment of the present invention.

FIG. 2 is a perspective view of a cap remover in accordance with anembodiment of the present invention.

FIG. 3 is a first elevation view of a cap remover in accordance with anembodiment of the present invention.

FIG. 4 is a second elevation view of a cap remover in accordance with anembodiment of the present invention.

FIG. 5 is a third elevation view of a cap remover in accordance with anembodiment of the present invention.

FIG. 6 is a fourth elevation view of a cap remover in accordance with anembodiment of the present invention.

FIG. 7 is a fifth elevation view of a cap remover in accordance with anembodiment of the present invention.

FIG. 8 is a sixth elevation view of a cap remover in accordance with anembodiment of the present invention.

FIG. 9 is a perspective view of a cap remover in accordance with anembodiment of the present invention.

FIG. 10 is a perspective view of a medical injector with a cap inaccordance with an embodiment of the present invention.

FIG. 11 is a perspective view of a medical injector in accordance withan embodiment of the present invention.

FIG. 12 is a cross-sectional view of a medical injector in accordancewith an embodiment of the present invention.

FIG. 13 is a perspective view of a medical injector with a cap removerin accordance with an embodiment of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

In the following discussion, “distal” refers to a direction generallytoward an end of a medical injector adapted for contact with a patientand/or engagement with a separate device, and “proximal” refers to theopposite direction of distal, i.e., away from the end of a medicalinjector adapted for engagement with the separate device. For purposesof this disclosure, the above-mentioned references are used in thedescription of the components of a medical injector in accordance withthe present disclosure.

FIGS. 1-13 illustrate an exemplary embodiment of the present disclosure.Referring to FIGS. 1-9 and 13 , a cap remover or a second cap 32 of thepresent disclosure is illustrated. Referring to FIGS. 10-13 , in oneembodiment, a medical injector 10 of the present disclosure includes afirst cap 30 and a second cap or cap remover 32. For example, referringto FIG. 13 , the second cap 32 can be secured to the medical injector 10such that the second cap or cap remover 32 shields and covers a distalend 50 of a needle 14 and the first cap 30. Referring to FIG. 10 , thefirst cap 30 shields and covers a distal end 50 of a needle 14. Thefirst cap 30 may be formed of a plastic and/or rubber guard material.The second cap 32 may be formed from a harder material than the firstcap 30. In one embodiment, the second cap 32 may be the only cap thatshields and covers the distal end 50 of the needle 14.

In one embodiment, with the first cap 30 covering the distal end 50 ofthe needle 14 and with the second cap 32 covering the distal end 50 ofthe needle 14 and the first cap 30, the second cap 32 is engaged withthe first cap 30 via a friction fit such that removal of the second cap32 simultaneously removes the first cap 30 from the distal end 50 of theneedle 14.

Referring to FIGS. 10-12 , a medical injector 10 includes a needleassembly 12 having a needle 14, an injector housing 16, a barrel 18having a reservoir 20 for medicament sealed by a septum 22, a stopper24, a plunger rod 26 having a flange 68, a spring 28, a first cap 30,and a second cap or a cap remover 32.

The medical injector 10 includes a distal end 34 and a proximal end 36.The reservoir 20 of the barrel 18 is encased within the injector housing16. In one embodiment, the reservoir 20 may be defined by the injectorhousing 16. In another embodiment, the reservoir 20 may be defined by aseparate component contained within the injector housing 16, e.g., acartridge or barrel. The needle assembly 12 includes a needle 14 and ahub 38. The needle 14 includes a distal end 50, formed for insertioninto a patient, and a proximal end 52.

The medical injector 10 of the present disclosure may be of variousforms, including being a syringe, self-injector, auto-injector, or peninjector. In one embodiment, the medical injector 10 is well-suited foradministering at least one fixed dose. In another embodiment, themedical injector 10 is well-suited for administering a series of fixeddoses. The medical injector 10 may be configured in any way known to becompatible with the plunger rod 26. The medical injector 10 may includea reservoir 20 for accommodating an injectable medicament, which may bea drug cartridge or formed directly in the medical injector 10. Thereservoir 20 may have one or more stoppers 24 associated therewith.

Referring to FIGS. 10-11 , the injector housing 16 of the medicalinjector 10 includes an upper guard 40, a lower guard 42, and a base 44.The upper guard 40 includes a first flange 46 and a first tapered wall48. In one embodiment, the upper guard 40 provides a gripping componentthat includes surfaces for accommodating a user's fingers, such asfinger grip indentations or similar structure. For example, the upperguard 40 provides ergonomically shaped surfaces that substantiallyconform to a user's fingertips to aid the user in manipulating themedical injector 10 and using the medical injector 10 in a medicalprocedure, and may provide multiple finger grip positions for the user.The upper guard 40 allows a user to handle and/or grip the medicalinjector 10 in a variety of different ways.

The lower guard 42 includes a second flange 60 and a second tapered wall62. The lower guard 42 provides a second gripping component thatincludes surfaces for accommodating a user's fingers, such as fingergrip indentations or similar structure. In one embodiment, the lowerguard 42 provides a user with vertical stability in hand, preciselyduring needle insertion with the medical injector 10.

The upper guard 40 and the lower guard 42 together provide a grippingcomponent that includes surfaces for accommodating a user's fingers toaid the user in manipulating the medical injector 10 and using themedical injector 10 in a medical procedure.

The base 44 includes a flange 64 that contacts the skin of a user duringuse of the medical injector 10. The base 44 provides a stabilitycomponent that stabilizes the medical injector 10 on a user's skinduring use of the medical injector 10. In one embodiment, the base 44also hides the spring 28.

Referring to FIGS. 10-11 , the injector housing 16, the upper guard 40,the lower guard 42, and the base 44 are configured to provide viewingwindows 66. The viewing windows 66 allow a user to see the barrel 18that includes the medicament.

Referring to FIG. 10 , a first cap 30 shields and covers the distal end50 of the needle 14. Referring to FIG. 13 , in one embodiment, thesecond cap or cap remover 32 shields and covers the distal end 50 of theneedle 14 and the first cap 30. In one embodiment, the second cap 32 maybe the only cap that shields and covers the distal end 50 of the needle14.

Referring to FIGS. 1-9 , the second cap or cap remover 32 includes abody 100 having a distal end 101, a proximal end 102, a distal flange104 including a first wing flange 106 and a second wing flange 108, asidewall 110, a first side aperture 112, a second side aperture 114, acavity 116, a distal aperture 118, and ribs 120. Referring to FIGS. 1-9, in one embodiment, the second cap 32 has a generally upside downT-shaped body. In some embodiments, the first cap 30 is viewable throughthe side apertures 112, 114 or side viewing windows. In someembodiments, the two side apertures 112, 114 may be provided through thesame or opposing sidewalls 110 of the second cap 32 for viewingengagement of the second cap 32 with the first cap 30.

Referring to FIG. 2 , in one embodiment, an interior wall 103 of thebody 100 defines a cavity 116 in a proximal end 102 of the body 100. Thecavity 116 is sized and shaped to receive at least a portion of thefirst cap 30 therein. A protrusion or rib 120 may extend inwardly fromthe interior wall 103 toward a longitudinal axis L of the body 100. Inone embodiment, the protrusion 120 is an annular rib. In anotherembodiment, the second cap 32 includes a plurality of ribs 120. Theplurality of ribs 120 may include a tapered proximal surface 122. Theproximal surface 122 may be angled from the interior wall 103 inwardlytoward the longitudinal axis L of the body 100 and downwardly toward thedistal end 101 of the body 100. The tapered proximal surface 122 aidsthe second cap 32 in sliding over the first cap 30 and securing thefirst cap 30 within the cavity 116. When the second cap 32 covers thefirst cap 30 the second cap or cap remover 32 shields and covers thedistal end 50 of the needle 14 and the first cap 30.

With the first cap 30 covering the distal end 50 of the needle 14 andwith the second cap 32 covering the distal end 50 of the needle 14 andthe first cap 30, the second cap 32 is engaged with the first cap 30 viaa friction fit such that removal of the second cap 32 simultaneouslyremoves the first cap 30 from the distal end 50 of the needle 14. In oneembodiment, the second cap or the cap remover 32 is removed from themedical injector 10 by applying a distally directed force F to thesecond cap or cap remover 32, as shown in FIG. 13 .

In one embodiment, the second cap 32 provides a gripping component thatincludes surfaces for accommodating a user's fingers, such as distalflange 104 including a first wing flange 106 and a second wing flange108 or similar structure. The first wing flange 106 and the second wingflange 108 may extend laterally from opposing sides of the body 100. Thefirst wing flange 106 and the second wing flange 108 of the second cap32 may provide ergonomically shaped surfaces that substantially conformto a user's fingertips to aid the user in removing the second cap 32from the distal end 50 of the needle 14 and/or to aid the user insimultaneously removing the second cap 32 and the first cap 30 from thedistal end 50 of the needle 14. For example, each of the first wingflange 106 and the second wing flange 108 of the second cap 32 mayinclude a curved proximal surface 124 providing a user with multiplefinger grip positions. The first wing flange 106 and the second wingflange 108 of the second cap 32 allow a user to handle and/or grip thesecond cap 32 in a variety of different ways. In one embodiment, theshape of the second cap 32 is designed to help disabled people moreeasily and more conveniently handle the second cap 32 and/or the medicalinjector 10. The first wing flange 106 and the second wing flange 108 ofthe second cap 32 may further include a substantially flat distalsurface 126 such that the second cap 32 may be placed and rested on aflat surface.

In one embodiment, the first wing flange 106 and the second wing flange108 of the second cap 32 allow a user to handle the second cap 32without finger flexion. In one embodiment, the first wing flange 106 andthe second wing flange 108 of the second cap 32 provide a grippingcomponent that allows a user to better handle the second cap 32 and/orthe medical injector 10.

When it is desired to use the medical injector 10 of the presentdisclosure, a user applies a removal force, such as a distally directedforce to the second cap 32, to easily and simultaneously remove thefirst cap 30 from the distal end 50 of the needle 14. Referring to FIG.11 , with the caps 30, 32 removed, the distal end 50 of the needle 14 isexposed and ready to be positioned adjacent a desired portion of theskin of a user.

When it is desired to expel or deliver the medication contained withinthe barrel 18 of the medical injector 10, and with the medical injector10 properly used to contact and pierce the skin of a user, the flange 68of the plunger rod 26 and a portion of the injector housing 16 can begrasped, e.g., with the user's thumb on the flange 68 of the plunger rod26 and with the user's fingers extending around the first flange 46 ofthe upper guard 40 of injector housing 16. In this manner, the medicalinjector 10 can be grasped by a user in a well-known and well-recognizedmanner similar to the operation of a conventional hypodermic syringe.Next, the user effects a squeezing movement between the thumb on theflange 68 of the plunger rod 26 and four fingers grasping the firstflange 46 of the upper guard 40, thereby causing the plunger rod 26 tomove in a direction generally along arrow A (FIG. 11 ).

Movement of the plunger rod 26 in the direction generally along arrow Aactuates movement of the stopper 24 in the direction generally alongarrow A toward the distal end 34 of the medical injector 10. In thismanner, movement of the stopper 24 in the direction generally alongarrow A forces the medicament fluid contained within the reservoir 20 ofthe barrel 18 to be forced out the distal end 50 of the needle 14 andinto the user and/or patient.

After injection of the medicament fluid, the needle 14 can be removedfrom the skin of the patient. In one embodiment, the medical injector 10may include an automatic retraction mechanism for moving the needle 14into the injector housing 16 for safe shielding of the needle 14 afteruse. In one embodiment, the spring 28 may be used as part of theautomatic retraction mechanism.

All of the components of the medical injector 10 may be constructed ofany known material, and are desirably constructed of medical-gradepolymers. While this disclosure has been described as having exemplarydesigns, the present disclosure can be further modified within thespirit and scope of this disclosure. This application is thereforeintended to cover any variations, uses, or adaptations of the disclosureusing its general principles. Further, this application is intended tocover such departures from the present disclosure as come within knownor customary practice in the art to which this disclosure pertains andwhich fall within the limits of the appended claims.

What is claimed is:
 1. A medical injector comprising: a housing; aneedle extending from the housing, the needle having a sharpened end; afirst cap covering the sharpened end of the needle; and a second capcovering at least a part of the first cap, the second cap comprising: acap body having a distal end, a proximal end, and an interior wall; atleast one protrusion extending inwardly from the interior wall; a firstwing flange extending from a portion of the cap body in a firstdirection, wherein the first wing flange comprises a curved proximallydirected and convex surface; and a second wing flange extending from aportion of the cap body in a second direction different from the firstdirection, wherein the second wing flange comprises a curved proximallydirected and convex surface, wherein the at least one protrusion of thesecond cap is engaged with the first cap such that removal of the secondcap via a distally-directed force simultaneously removes the first capfrom the sharpened end of the needle.
 2. The medical injector of claim1, wherein the second cap engages the first cap via a friction fit. 3.The medical injector of claim 1, wherein the interior wall defines acavity in the proximal end of the second cap, wherein the cavity issized and shaped to receive at least a portion of the first cap.
 4. Themedical injector of claim 1, wherein the at least one protrusion is aplurality of protrusions and wherein the plurality of protrusions areadapted to frictionally engage the first cap.
 5. The medical injector ofclaim 1, wherein the at least one protrusion comprises a tapered surfacefor aiding the second cap in receiving the first cap.
 6. The medicalinjector of claim 1, wherein the at least one protrusion is an annularrib.
 7. The medical injector of claim 1, wherein a window is definedthrough a sidewall of the second cap for visually viewing engagement ofthe second cap with the first cap.
 8. The medical injector of claim 1,wherein the first cap comprises a first material and the second capcomprises a second material, wherein the first material is differentfrom the second material.
 9. The medical injector of claim 8, whereinthe second material is harder than the first material.
 10. The medicalinjector of claim 1, wherein the first cap comprises an elastomericsleeve disposed over at least the sharpened first end of the needle. 11.The medical injector of claim 1, wherein the first and second wingflanges extend from opposing sides of the cap body.
 12. The medicalinjector of claim 1, wherein the first and second wing flanges eachcomprise a curved proximally directed surface.
 13. The medical injectorof claim 1, wherein the first and second wing flanges each comprise asubstantially flat distally directed surface.
 14. The medical injectorof claim 1, wherein the second cap is T-shaped.
 15. A cap remover forremoving a needle cap covering a sharpened end of a needle, the capremover comprising: a cap body having a proximal end and a distal end,and an interior wall defining a cavity sized and shaped to receive theneedle cap therein; at least one protrusion extending inwardly from theinterior wall of the cap body; a first wing flange extending from thedistal end of the cap body in a first direction; and a second wingflange extending from the distal end of the cap body in a seconddirection different from the first direction, wherein each of the firstwing flange and the second wing flange comprise a curved proximallydirected and convex surface and a flat distally directed surface. 16.The cap remover of claim 15, wherein the at least one protrusion is aplurality of protrusions extending inwardly from the interior wall ofthe cap body.
 17. The cap remover of claim 16, wherein at least one ofthe plurality of protrusions comprises a tapered proximal surface. 18.The cap remover of claim 15, wherein the at least one protrusion isadapted to frictionally engage the needle cap.
 19. The cap remover ofclaim 18, wherein, with the at least one protrusion of the cap bodyengaged with the needle cap, the cap remover disengages the needle capfrom the needle upon application of a distally-directed force on the capremover.
 20. The cap remover of claim 15, further comprising a viewingwindow extending through a portion of the cap body.